Paper # 554 
Resistance-associated Mutations to Integrase Inhibitor S/GSK1349572 in HIV-1 Integrase Inhibitor-naive and Raltegravir-experienced Patients
Anne-Genevieve Marcelin*1, I Malet1, L Fabeni2, D Armenia2, S Fourati1, B Masquelier3, C Katlama1, C F Perno2, V Calvez1, and F Ceccherini-Silberstein2
1INSERM U943, Hosp Pitie-Salpetriere, Univ Pierre et Marie Curie, Paris, France; 2Univ of Rome Tor Vergata, Italy; and 3Hosp Bordeaux, France
Background: S/GSK1349572
is a next generation HIV-1 strand transfer integrase inhibitor (INI) with high
potency and putative activity on viruses resistant to first generation INI.
Little is known about the resistance profile of S/GSK1349572: In vitro serial
passage experiments identified 5 single or combined amino acid substitutions in
the integrase gene that are involved in the development of resistance to
S/GSK1349572 (T124A, T124A/S153F, S153Y, T124A/S153Y, and L101I/T124A/S153Y).
The aim of this study was to determine the prevalence of resistance mutations
to S/GSK1349572 in INI-naive and INI-experienced patients.
Methods: The sequences
of the entire integrase gene from 466 INI-naive patients infected with subtype
B HIV-1 strains and 84 INI-experienced (raltegravir-failing) patients infected
with subtype B were analyzed for the presence of previously described in
vitro mutations linked to resistance to S/GSK1349572. INI-experienced
patients were raltegravir (RAL)-failing patients with an integrase genotypic
test at failure after RAL starting regimen with a contextual HIV RNA value
>50 copies/mL.
Results: The mutations
L101I, T124A, and the double mutant L101I/T124A can be present in INI-naive
patients with frequencies of 45.3%, 28.1%, and 10.9%, respectively. In
INI-experienced patients failing to RAL, frequencies of L101I, T124A and
L101I/T124A were 57.1%, 35.7% and 20.2%, respectively. Thus, mutations L101I
and the double mutant L101I/T124A were statistically more frequent in
RAL-failing patients than in INI-naive patients with P-values =0.04 and
0.02, respectively. Neither the mutation S153Y nor the profiles T124A/S153F,
T124A/S153Y, and L101I/T124A/S153Y were identified in the sequences from INI
naive or experienced patients studied.
Conclusions: Some of the mutations
selected by in vitro passages with S/GSK1349572
are more frequent in patients failing RAL than in INI-naive patients. Thus, the
impact on virological response of L101I and T124A mutations alone and the
double mutant L101I/T124A should be further addressed in vivo in both
INI-naive patients and particularly in RAL-failing patients treated with
S/GSK1349572.
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